Abstract: A vascular introducer hub has a body that includes a proximal end, a distal end, and a lumen defined therethrough. The hub includes first and second seals disposed within the body. The first seal includes a first polymeric material and the second seal includes a second polymeric material. The hub is characterized by the first and second polymeric materials having different durometers.

Abstract: The present disclosure relates generally to electroporation systems and utilizing algorithms for electroporation pulse delivery including a patient's EKG/EGM monitoring. In some embodiments, an electroporation delivery system may include an electrocardiogram operatively connected to a processing device and a memory. One or more sensors may be operatively connected to the electrocardiogram for measuring electrical activity QRS complex of a patient's heart. One or more electrodes for treatment may be disposed in, at, or near the patient's heart, the one or more electrodes operatively connected to a pulse delivery mechanism. The electroporation delivery system may be configured to determine whether an electroporation pulse is deliverable to a patient based on the electrocardiogram.

Abstract: Tissue puncture devices, and systems and methods for accessing tissue (e.g., cardiovascular tissue) according to the present disclosure may include a tubular sheath extending along a longitudinal axis, the tubular sheath having a proximal end and a distal end, a needle disposed coaxially in the sheath, the needle having a proximal end and a distal end and being movable along the longitudinal axis of sheath, and a needle control mechanism disposed at the proximal end of the needle, the needle control mechanism being configured to lock the distal end of the needle in a first position retracted within the distal end of the sheath, and release the needle to an unlocked second position such that the distal end of the needle is extendable beyond the distal end of the sheath.

Abstract: Devices, systems, and method for adjusting and setting tension of an artificial chordae tendineae. The artificial chordae tendineae is coupleable between a leaflet clip and a tissue anchor. A locking assembly, through which the artificial chordae tendineae extends, is shiftable between a tension-adjusting configuration, in which the artificial chordae tendineae is movable to adjust tension on the leaflet, and a tension-setting or locked configuration, in which the artificial chordae tendineae is inhibited or prevented or locked against moving with respect to the locking assembly to set or fix tension on the leaflet.

Abstract: A medical system includes a shaft having a proximal end and a distal end, a balloon attached to the distal end of the shaft, the balloon movable between an expanded state and a deflated state where a maximum diameter of the balloon is greater in the expanded state than in the deflated state, and an electrode is attached to the shaft where a portion of the balloon includes a plurality of apertures fluidly connecting an interior of the balloon to an exterior of the balloon.

Abstract: Tissue puncture devices, and systems and methods for accessing tissue (e.g., cardiovascular tissue) according to the present disclosure may include a tubular sheath extending along a longitudinal axis, the tubular sheath having a proximal end and a distal end, a needle disposed coaxially in the sheath, the needle having a proximal end and a distal end and being movable along the longitudinal axis of sheath, and a needle control mechanism disposed at the proximal end of the needle, the needle control mechanism being configured to lock the distal end of the needle in a first position retracted within the distal end of the sheath, and release the needle to an unlocked second position such that the distal end of the needle is extendable beyond the distal end of the sheath.

Abstract: A heart valve anchor has a body that includes a distal portion, a distal end, a proximal portion, and a proximal end. The distal end and the proximal end define a longitudinal axis. The body has an expandable portion that includes a first radially expandable portion at the distal portion of the body, a second radially expandable portion at the proximal portion of the body, and a root portion disposed between the first and second radially expandable portions. The body has a first configuration adapted to be housed at least partially within a tissue penetrating device, and a second configuration in which the first and second radially expandable portions are partially or fully expanded such that the anchor engages tissue in a region between the first and second radially expandable portions.

Abstract: A medical device comprising a tube, a first electrode and a second electrode, and a structure at a distal portion of the tube, the structure defining a first section and a second section, wherein the first and second sections are configured to be filled with a conductive medium, wherein the first electrode is contained within the first section, and the second electrode is contained within the second section, and wherein the structure includes a central barrier separating the first section from the second section, and the central barrier is insulative.

Abstract: The present disclosure relates generally to apparatuses and methods for delivering an occlusion device to a paravalvular leak. In some embodiments, a paravalvular occlusion apparatus includes a catheter having main body including a proximal end and a distal end, a visualization element disposed in the distal end of the main body, and a working channel extending from the distal end of the main body. The catheter further includes an elongate shaft extendable from the working channel, wherein an occlusion device is coupled to the elongate shaft. In some embodiments, an occlusion device includes a leading end including a first section, and a trailing end opposite the leading end, the trailing end including a second section. The first section and the second section of the occlusion device are operable to be positioned along a perimeter of a prosthetic valve for blocking the paravalvular leak.

Abstract: An introducer catheter device comprising a handle and an elongate shaft coupled to the handle and extending therefrom. The shaft defines a lumen therethrough, a longitudinal axis, and a first aperture in connection with the lumen. The shaft includes a movable deployment element configured for deploying an ancillary device from the first aperture at an angle relative to the longitudinal axis.

Abstract: A valve fixation device may comprise a unitary elongate member that is biased towards a closed configuration wherein at least a pair of tissue engaging surfaces of the elongate member are held adjacent to each other by a bias force. The bias force is at least equal to a valve leaflet grasping force, enabling the fixation device to grasp and retain leaflets as part of cardiac treatment. A delivery tool including a spreader may independently translate the tissue engaging surfaces to enable cardiac leaflets to be captured and retained by and/or between the tissue engaging surfaces. The valve fixation device may include at least two arms, each of which may be independently controlled to grasp and capture opposing leaflets of a valve, such as the anterior and posterior leaflets of a mitral valve, to reduce the size of the valve opening and improve cardiac performance.

Abstract: Anchor delivery systems and methods for repairing a valve inside a body, such as a heart valve, may include a delivery catheter having a distal end comprised of two or more rotatably coupled knuckles. An anchor delivery mechanism is disposed distally of the two or more knuckles, and includes a first pincer arm having a distal end and a proximal end rotatably coupled to a distal end of the anchor delivery mechanism at a first connection point, and a second pincer arm having a distal end and a proximal end rotatably coupled to the distal end of the anchor delivery mechanism at a second connection point opposite the first connection point. In a closed position, the distal ends of the first and second pincer arms are positioned together. In an open position, the distal ends of the first and second pincer arms are rotated apart from each other.

Abstract: A device includes a hollow needle with a lumen extending therethrough. The needle is sized and shaped to extend through an endoscopic shaft to a target tissue within a living body. The needle has a distal end with a sharpened distal tip for puncturing the target tissue and removing a portion of the tissue in the lumen. The device further includes a cylindrical stylet having a shaft sized and shaped to extend through the lumen of the needle and a distal end with a pointed distal tip for puncturing the target tissue. When the stylet is extended, the pointed distal tip of the stylet extends distally a predetermined distance past the sharpened distal tip of the needle.

Abstract: Anchor delivery systems and methods for repairing a valve inside a body, such as an atrioventricular valve, may include an anchor delivery device including a sheath for at least partially retaining an anchor in a collapsed form. The anchor delivery device may be configured to deliver the anchor to the atrioventricular valve. The anchor and an adjacent anchor may be connectable to each other in an expanded form, to link a series of anchors implanted at least partially around the atrioventricular valve. In some embodiments, the anchors may be connectable by a connecting member, such as a pledget, or a material disposable on a bulb of the anchor. In other embodiments, a bulb of the anchor and a bulb of the adjacent anchor may be configured to be directly interlocked.

Abstract: The present disclosure relates generally to the field of medical devices for clamping a leaflet of a heart valve. In particular, the present disclosure relates to medical devices, systems, and methods for delivering artificial chordae tendineae in a patient. In an embodiment, a system may include a clamp having a plurality of arms at a first end. The plurality of arms may have a closed configuration in which the arms are oriented toward each other, and an open configuration in which the arms are oriented away from each other. A spring portion may be coupled to the plurality of arms at a second end that is configured to bias the arms to the closed configuration. The arms of the clamp may be configured to fixedly engage with a leaflet of the heart valve. The second end of the clamp may be configured to couple to an artificial chordae tendineae.

Abstract: The present disclosure relates generally to the field of medical devices for delivering artificial chordae tendineae in a patient. A system for adjusting tension in an artificial chordae tendineae includes an artificial chordae tendineae coupleable between a clip and an anchor. The clip is engageable with a leaflet of a heart valve while the anchor is engageable with a papillary muscle or heart wall. The anchor includes a body portion, and a locking portion coupleable with the artificial chordae tendineae and configured to allow movement of the artificial chordae tendineae in a first direction while preventing movement of the artificial chordae tendineae in a second direction opposite the first direction. An actuator is coupled to the locking portion for selectively releasing the locking portion to enable selective movement of the artificial chordae tendineae in the second direction.

Abstract: The present disclosure relates generally to the field of medical devices for treating heart disease. In particular, the present disclosure relates to medical devices, systems, and methods for delivering artificial chordae tendineae in a patient. A system for delivering a chordae tendineae into a heart may include a delivery catheter. A clamp catheter may be configured to translate through the delivery catheter. A spreader may be disposed on the clamp catheter. A first clamp may be at least partially contained in the spreader in a closed configuration and may be attached to the chordae tendineae. An anchor catheter may be configured to translate through the delivery catheter and may have an anchor attached to the chordae tendineae. A sheath may be extended over the anchor catheter and anchor and may be configured to restrain an arm of the anchor.

Abstract: The present disclosure relates generally to the field of medical devices for delivering artificial chordae tendineae in a patient. In an embodiment, an anchor is movable between a delivery configuration and a deployed configuration, the anchor being in the delivery configuration when disposed within a delivery catheter, the anchor being in the deployed configuration when the anchor is moved beyond a distal end of the delivery catheter. When the anchor is in the delivery configuration it has a first outer dimension and when the anchor is in the deployed configuration it has a second outer dimension, the first outer dimension being smaller than the second outer dimension. The anchor is engageable with a papillary muscle or a heart wall when the anchor is in the deployed configuration and is also coupleable to an artificial chordae tendineae to anchor the artificial chordae tendineae to the papillary muscle or heart wall.

Abstract: A minimally invasive endoluminal annuloplasty system and method of use includes a guide catheter configured to direct a working catheter to a treatment site within a cardiac cavity. The guide catheter may be translatably disposed within the working catheter which may be translatably disposed within an introducer sheath that extends into the cardiac cavity. The guide catheter may be sized to reduce noise, and/or may be formed from a material that assists with visualization. In one embodiment the guide catheter comprises a distal guidewire anchor. Visualization may be used to embed the distal guidewire anchor into tissue at the target site.

Abstract: A medical device made of a hybrid polymeric structure includes a tubular body including a first layer and a second layer. The first layer includes a fibrous matrix comprising a plurality of randomly oriented nanofibers made at least in part of a first polymeric material and pores formed between at least a portion of the nanofibers. The second layer is made at least in part of a second polymeric material. At least a portion of the second layer is disposed about and between the plurality of nanofibers such that at least a portion of the second polymeric material is embedded into at least a portion of the pores of the fibrous matrix.